510(k) K260405

FiberTape Button by Arthrex, Inc. — Product Code MBI

K260405 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "FiberTape Button". The FDA issued a decision of Substantially Equivalent on March 9, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrex, Inc. has at least 10 other 510(k) clearances on record.